U.S. patent application number 15/596604 was filed with the patent office on 2018-04-05 for method and apparatus for straightening and flattening the side wall of a body lumen or body cavity so as to provide three dimensional exposure of a lesion or abnormality within the body lumen or body cavity, and/or for stabilizing an instrument relative to the same.
The applicant listed for this patent is Cornell University. Invention is credited to Robert Andrews, John Frederick Cornhill, Edward Dickinson, Jeffrey Milsom, Howard Riina.
Application Number | 20180092636 15/596604 |
Document ID | / |
Family ID | 41610713 |
Filed Date | 2018-04-05 |
United States Patent
Application |
20180092636 |
Kind Code |
A1 |
Milsom; Jeffrey ; et
al. |
April 5, 2018 |
METHOD AND APPARATUS FOR STRAIGHTENING AND FLATTENING THE SIDE WALL
OF A BODY LUMEN OR BODY CAVITY SO AS TO PROVIDE THREE DIMENSIONAL
EXPOSURE OF A LESION OR ABNORMALITY WITHIN THE BODY LUMEN OR BODY
CAVITY, AND/OR FOR STABILIZING AN INSTRUMENT RELATIVE TO THE
SAME
Abstract
Apparatus for straightening and flattening a side wall of a body
lumen or body cavity so as to provide three dimensional exposure of
a lesion or abnormality within the body lumen or body cavity, and
simultaneously providing for the stabilization or docking of the
working end of an endoscope or surgical tool, the apparatus
comprising: a deployable hoop expander comprising a structure
defining a volume; the deployable hoop expander being configured so
as to be transitionable between (i) a reduced cross-sectional
configuration, and (ii) an expanded cross-sectional configuration,
whereby the deployable hoop expander can be configured in its
reduced cross-sectional configuration for easy insertion into a
body lumen, and it can thereafter be re-configured into its
expanded cross-sectional configuration so as to engage, straighten
and flatten the side wall of the body lumen, whereby to provide
three dimensional exposure of the lesion or abnormality within the
body lumen or body cavity, the deployable hoop expander being
configured for simultaneously providing for the docking of the end
of the endoscope or other instrument so as to stabilize the same
for endoscopic viewing and/or therapy.
Inventors: |
Milsom; Jeffrey; (New York,
NY) ; Riina; Howard; (Scarsdale, NY) ;
Cornhill; John Frederick; (New York, NY) ; Andrews;
Robert; (Norfolk, MA) ; Dickinson; Edward;
(Littleton, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cornell University |
Ithaca |
NY |
US |
|
|
Family ID: |
41610713 |
Appl. No.: |
15/596604 |
Filed: |
May 16, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12511256 |
Jul 29, 2009 |
9649100 |
|
|
15596604 |
|
|
|
|
61137361 |
Jul 30, 2008 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/91 20130101; A61F
2/86 20130101; A61F 2/88 20130101; A61F 2230/008 20130101; A61F
2002/045 20130101; A61F 2/95 20130101; A61F 2250/0059 20130101;
A61B 1/00087 20130101; A61F 2002/9528 20130101; A61B 17/0218
20130101 |
International
Class: |
A61B 17/02 20060101
A61B017/02; A61B 1/00 20060101 A61B001/00; A61F 2/86 20060101
A61F002/86 |
Claims
1. Apparatus for straightening and flattening a side wall of a body
lumen or body cavity, so as to provide three dimensional exposure
of a lesion or abnormality within the body lumen or body cavity,
the apparatus comprising: an endoscope having a distal end for
insertion into the body lumen or body cavity, and a proximal end
for disposition outside of the body lumen or body cavity; a
deployable expander comprising a distal end, a proximal end and
defining a volume therebetween; the deployable expander being
configured so as to be transitionable between (i) a reduced
cross-sectional configuration, and (ii) an expanded cross-sectional
configuration, whereby the deployable expander can be configured in
its reduced cross-sectional configuration for easy insertion into a
body lumen, and it can thereafter be re-configured into its
expanded cross-sectional configuration so as to engage, straighten
and flatten the side wall of the body lumen, whereby to provide
three dimensional exposure of the lesion or abnormality within the
body lumen or body cavity; the proximal end of the deployable
expander being configured for mounting to the endoscope such that
the distal end of the endoscope is supported and stabilized
relative to the body lumen or body cavity when the deployable
expander is in its expanded cross-sectional configuration within
the body lumen or body cavity.
2. (canceled)
3. (canceled)
4. Apparatus according to claim 1 wherein the deployable expander
comprises a plurality of parallel rings connected to one another by
at least one strut.
5. Apparatus according to claim 4 wherein the parallel rings have a
circular configuration.
6. (canceled)
7. Apparatus according to claim 4 wherein the parallel rings have
diameters which vary along the length of the deployable expander,
such that the deployable expander can form a non-cylindrical and
non-ovoid geometry when it is in its expanded cross-sectional
configuration.
8. Apparatus according to claim 7 wherein the deployable expander
has a spherical configuration.
9.-11. (canceled)
12. Apparatus according to claim 1 wherein the deployable expander
is resilient and is normally biased into its expanded
cross-sectional configuration, and further wherein the apparatus
comprises a constraint for maintaining the deployable expander in
its reduced cross-sectional configuration.
13. (canceled)
14. (canceled)
15. Apparatus according to claim 12 wherein the constraint
comprises a sleeve.
16.-20. (canceled)
21. Apparatus according to claim 1 wherein the distal end of the
deployable expander is closed.
22. Apparatus according to claim 1 wherein the proximal end of the
deployable expander is partially closed.
23. (canceled)
24. Apparatus according to claim 1 wherein the deployable expander
comprises a biocompatible material.
25. Apparatus according to claim 1 wherein the deployable expander
comprises a superelastic alloy material.
26. Apparatus according to claim 1 wherein the deployable expander
comprises a shape memory alloy material.
27. Apparatus according to claim 1 wherein the deployable expander
comprises a polymeric material.
28. Apparatus according to claim 24 wherein the biocompatible
material is a biodegradable/absorbable material.
29. (canceled)
30. Apparatus according to claim 1 wherein the deployable expander
is configured to be passed over the outside of an endoscope.
31. Apparatus according to claim 1 wherein the deployable expander
is configured to be passed alongside of an endoscope.
32. A method for straightening and flattening a side wall of a body
lumen or body cavity so as to provide three dimensional exposure of
a lesion or abnormality within the body lumen or body cavity, the
method comprising: providing apparatus comprising: an endoscope
having a distal end for insertion into the body lumen or body
cavity, and a proximal end for disposition outside of the body
lumen or body cavity; a deployable expander comprising a distal
end, a proximal end and defining a volume therebetween; and the
deployable expander being configured so as to be transitionable
between (i) a reduced cross-sectional configuration, and (ii) an
expanded cross-sectional configuration, whereby the deployable
expander can be configured in its reduced cross-sectional
configuration for easy insertion into a body lumen, and it can
thereafter be re-configured into its expanded cross-sectional
configuration so as to engage, straighten and flatten the side wall
of the body lumen, whereby to provide three dimensional exposure of
the lesion or abnormality within the body lumen or body cavity; the
proximal end of the deployable expander being configured for
mounting to the endoscope such that the distal end of the endoscope
is supported and stabilized relative to the body lumen or body
cavity when the deployable expander is in its expanded
cross-sectional configuration within the body lumen or body cavity;
configuring the deployable expander in its reduced cross-sectional
configuration; advancing the deployable expander into a body lumen
or body cavity; and re-configuring the deployable expander into its
expanded cross-sectional configuration so as to engage, straighten
and flatten the side wall of the body lumen or body cavity, whereby
to provide three dimensional exposure of the lesion or abnormality
within the body lumen or body cavity.
33. A method according to claim 32 wherein the method comprises the
additional steps of: re-configuring the deployable expander into
its reduced cross-sectional configuration; and removing the
deployable expander from the body lumen or body cavity.
34. (canceled)
35. (canceled)
36. A method according to claim 32 wherein the deployable expander
is resilient and is normally biased into its expanded
cross-sectional configuration, and further wherein the apparatus
comprises a constraint for maintaining the deployable expander in
its reduced cross-sectional configuration.
37. A method according to claim 36 wherein the deployable expander
is (i) configured in its reduced cross-sectional configuration by
compressing the deployable expander and then applying the
constraint so as to maintain the deployable expander in its reduced
cross-sectional configuration; and (ii) re-configured into its
expanded cross-sectional configuration by releasing the
constraint.
38.-40. (canceled)
41. A method according to claim 37 wherein the constraint comprises
an outer sleeve.
42. A method according to claim 41 wherein the constraint is
released by removing the outer sleeve.
43.-45. (canceled)
46. A method according to claim 32 wherein the deployable expander
is advanced into the body lumen by passing it over the outside of
an endoscope.
47. A method according to claim 32 wherein the deployable expander
is advanced into the body lumen by passing it alongside of an
endoscope.
48. (canceled)
49. (canceled)
50. Apparatus for straightening and flattening a side wall of a
body lumen or body cavity, so as to provide three dimensional
exposure of a lesion or abnormality within the body lumen or body
cavity, the apparatus comprising: a deployable expander comprising
a distal end, a proximal end and defining a volume therebetween;
the deployable expander being configured so as to be transitionable
between (i) a reduced cross-sectional configuration, and (ii) an
expanded cross-sectional configuration, whereby the deployable
expander can be configured in its reduced cross-sectional
configuration for easy insertion into a body lumen, and it can
thereafter be re-configured into its expanded cross-sectional
configuration so as to engage, straighten and flatten the side wall
of the body lumen, whereby to provide three dimensional exposure of
the lesion or abnormality within the body lumen or body cavity;
wherein the proximal end of the deployable expander is configured
to be mounted to the distal end of an endoscope disposed in the
body lumen, such that the deployable expander extends around the
perimeter of a portion of the endoscope proximate to the distal end
of the endoscope, and such that the deployable expander engages,
straightens and flattens the side wall of the body lumen, when the
deployable expander is in its expanded cross-sectional
configuration within the body lumen or body cavity.
Description
REFERENCE TO PENDING PRIOR PATENT APPLICATION
[0001] This patent application claims benefit of pending prior U.S.
Provisional Patent Application Ser. No. 61/137,361, filed Jul. 30,
2008 by Jeffrey Milsom et al. for METHOD AND APPARATUS FOR
STRAIGHTENING AND FLATTENING THE SIDE WALL OF A BODY LUMEN OR BODY
CAVITY SO AS TO PROVIDE THREE DIMENSIONAL EXPOSURE OF A LESION OR
ABNORMALITY WITHIN THE BODY LUMEN OR BODY CAVITY, AND/OR FOR
STABILIZING AN INSTRUMENT RELATIVE TO THE SAME (Attorney's Docket
No. CORN-0311 PROV), which patent application is hereby
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] This invention relates to surgical methods and apparatus in
general, and more particularly to surgical methods and apparatus
for straightening and flattening the side wall of a body lumen or
body cavity so as to provide three dimensional exposure of a lesion
or abnormality within the body lumen or body cavity, and/or for
stabilizing an instrument relative to the same.
BACKGROUND OF THE INVENTION
[0003] The human body comprises many different lumens and cavities.
By way of example but not limitation, the human body comprises
lumens such as the gastrointestinal (GI) tract, blood vessels,
lymph nodes, the ureter, etc. By way of further example but not
limitation, the human body comprises cavities such as the abdomen,
the chest, the nasal sinuses, the bladder, etc.
[0004] In many cases, it may be desirable to endoscopically examine
and/or treat a disease process or abnormality within or on the side
wall of a body lumen and/or body cavity. By way of example but not
limitation, it may be desirable to examine the lumen or side wall
of the gastrointestinal tract for lesions and, if a lesion is
found, to biopsy, remove, and/or treat the lesion.
[0005] The endoscopic examination and/or treatment of the side wall
of a body lumen and/or body cavity can be complicated by the
geometry of the side wall of the body lumen or body cavity. By way
of example but not limitation, the intestine is an elongated organ
having an inner lumen characterized by frequent turns and side
walls characterized by numerous folds. It can be difficult to
examine and/or treat a lesion formed on the side wall of the
intestine due to this varying side wall geometry.
[0006] It would be advantageous to provide an endoscopic device
capable of straightening and flattening the side wall of a body
lumen or body cavity so as to better present the side wall tissue
for examination and/or treatment during an endoscopic
procedure.
[0007] It would also be advantageous to provide an endoscopic
device capable of steadying, or maintaining in a fixed position,
the tip(s) or working end(s) of an instrument (or instruments)
inserted into a body space.
SUMMARY OF THE INVENTION
[0008] The present invention comprises the provision and use of a
novel endoscopic device capable of straightening and flattening the
side wall of a body lumen or body cavity so as to better expose or
present the side wall tissue in all dimensions for examination
and/or treatment during an endoscopic procedure.
[0009] The present invention also comprises the provision and use
of a novel endoscopic device capable of steadying or stabilizing
the tip or working end of an instrument or several instruments.
[0010] In one preferred form of the present invention, there is
provided apparatus for straightening and flattening a side wall of
a body lumen or body cavity so as to provide three dimensional
exposure of a lesion or abnormality within the body lumen or body
cavity, the apparatus comprising:
[0011] a deployable hoop expander comprising a
longitudinally-extending structure defining a volume;
[0012] the deployable hoop expander being configured so as to be
transitionable between (i) a reduced cross-sectional configuration,
and (ii) an expanded cross-sectional configuration, whereby the
deployable hoop expander can be configured in its reduced
cross-sectional configuration for easy insertion into a body lumen,
and it can thereafter be re-configured into its expanded
cross-sectional configuration so as to engage, expose, straighten
and flatten the side wall of the body lumen, whereby to provide
three dimensional exposure of the lesion or abnormality within the
body lumen or body cavity.
[0013] In one preferred form of the present invention, the
deployable hoop expander comprises an open lattice configuration
allowing access to the lumen or side wall of the body lumen or body
cavity.
[0014] And in another preferred form of the present invention, the
deployable hoop expander is configured so as to allow an instrument
(or instruments) to dock with the deployable hoop expander, whereby
to permit the deployable hoop expander to steady or stabilize the
tip(s) or working end(s) of the instrument(s).
[0015] In another preferred form of the present invention, there is
provided a method for straightening and flattening a side wall of a
body lumen or body cavity so as to provide three dimensional
exposure of a lesion or abnormality within the body lumen or body
cavity, the method comprising:
[0016] providing a deployable hoop expander; [0017] the deployable
hoop expander comprising a longitudinally-extending structure
defining a volume; and [0018] the deployable hoop expander being
configured so as to be transitionable between (i) a reduced
cross-sectional configuration, and (ii) an expanded cross-sectional
configuration;
[0019] configuring the deployable hoop expander in its reduced
cross-sectional configuration;
[0020] advancing the deployable hoop expander into a body lumen;
and
[0021] re-configuring the deployable hoop expander into its
expanded cross-sectional configuration so as to engage, expose,
straighten and flatten the side wall of the body lumen, whereby to
provide three dimensional exposure of the lesion or abnormality
within the body lumen or body cavity.
[0022] In one preferred form of the present invention, the
deployable hoop expander comprises an open lattice configuration
allowing access to the side wall of the body lumen or body
cavity.
[0023] And in one preferred form of the present invention, the
deployable hoop expander is configured so as to allow an instrument
(or instruments) to dock with the deployable hoop expander, whereby
to permit the deployable hoop expander to steady or stabilize the
tip(s) or working end(s) of the instrument(s).
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] These and other objects and features of the present
invention will be more fully disclosed or rendered obvious by the
following detailed description of the preferred embodiments of the
invention, which is to be considered together with the accompanying
drawings wherein like numbers refer to like parts and further
wherein:
[0025] FIGS. 1-3 are schematic views showing a novel endoscopic
device formed in accordance with the present invention, wherein the
novel endoscopic device is being deployed in a body lumen so as to
straighten and flatten the side wall of the body lumen so as to
provide three dimensional exposure of a lesion or abnormality
within the body lumen or body cavity and/or to provide stability to
the working end of an instrument;
[0026] FIGS. 4-12 are schematic views showing various aspects of a
novel endoscopic device comprising a deployable hoop expander
formed out of spring material and constrained by an outer net;
[0027] FIGS. 13 and 14 are schematic views showing various aspects
of a novel endoscopic device comprising a deployable hoop expander
formed out of spring material and constrained by an outer
sleeve;
[0028] FIGS. 15-17 are schematic views showing various aspects of a
novel endoscopic device comprising a deployable hoop expander
erected with control wires;
[0029] FIGS. 18-20 are schematic views showing the use of a
grasping tool for repositioning or removing the deployable hoop
expander; and
[0030] FIGS. 21 and 22 are schematic views showing delivery of the
deployable hoop expander vis-a-vis an endoscope or other
device.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
The Novel Endoscopic (or Surgical) Device in General
[0031] The present invention comprises the provision and use of a
novel endoscopic (or surgical) device capable of straightening and
flattening the side wall of a body lumen or body cavity so as to
better present the side wall tissue for examination and/or
treatment during an endoscopic or surgical procedure and/or to
stabilize an instrument relative to the same.
[0032] More particularly, the present invention comprises the
provision and use of a novel endoscopic/surgical device for
facilitating the alignment and presentation of the side wall of a
body lumen or body cavity during an endoscopic or other surgical
procedure, and/or for stabilizing an instrument relative to the
same. In this respect, the term "endoscopic procedure" is intended
to mean substantially any minimally-invasive procedure, diagnostic
or surgical, for accessing the inside of a vessel or organ within
the body for purposes of viewing, biopsying and/or treating the
tissue (including removing a lesion), and the term surgical
procedure is intended to mean substantially any medical operative
procedure performed on the body. The novel endoscopic/surgical
device of the present invention (hereinafter sometimes referred to,
for convenience, as simply an endoscopic device) is adapted to
straighten and flatten bends and/or curves and/or folds in the side
wall of the vessel or organ, and can provide a platform for the
performance of numerous procedures within the vessel or organ,
including the possible docking and/or fixation of an endoscope
and/or other surgical instruments within the vessel or organ.
[0033] In accordance with the present invention, and looking now at
FIGS. 1-3, there is shown an endoscopic device 5 capable of
straightening and flattening the side wall of a body lumen or body
cavity so as to better present the side wall tissue for examination
and/or treatment during an endoscopic procedure, and/or for
stabilizing an instrument relative to the same. More particularly,
endoscopic device 5 generally comprises a deployable hoop expander
10 which generally comprises a plurality of parallel rings 15
connected together by a plurality of struts 20. Deployable hoop
expander 10 is configured so as to be transitionable between (i) a
reduced cross-sectional configuration (FIG. 1) wherein the planes
of the parallel rings 15 are disposed at an acute angle (when seen
in side view) to the longitudinal axis of deployable hoop expander
10, and (ii) an expanded cross-sectional configuration (FIG. 2)
wherein the planes of the parallel rings 15 are disposed
perpendicular (when seen in side view) to the longitudinal axis of
deployable hoop expander 10. As a result of this construction,
deployable hoop expander 10 can be configured in its reduced
cross-sectional configuration for easy insertion into a body lumen
(e.g., a vascular lumen, an organ lumen, etc.) 25 (FIG. 1), and it
can thereafter be re-configured into its expanded cross-sectional
configuration so as to engage, expose, straighten and flatten the
side wall 30 of body lumen 25 (FIG. 2). This engagement,
straightening and flattening of side wall 30 of body lumen 25
better presents the side wall tissue for examination and/or
treatment during an endoscopic procedure, e.g., such as one
utilizing an endoscopic instrument 35 (FIG. 3). By way of example
but not limitation, endoscopic instrument 35 may comprise an
endoscope carrying an extendable biopsy device 40 therein.
Preferably deployable hoop expander 10 has an open lattice
configuration allowing access to the side wall of the body lumen or
body cavity. In one preferred form of the invention, deployable
hoop expander 10 comprises a polygonal structure.
[0034] As will hereinafter be discussed in further detail,
deployable hoop expander 10 is preferably also configured so as to
allow an instrument (e.g., endoscopic instrument 35) to dock with
deployable hoop expander 10, whereby to permit the deployable hoop
expander to steady or stabilize the tip(s) or working end(s) of the
instrument (or instruments).
[0035] Parallel rings 15 can have a circular configuration (in
which case deployable hoop expander 10 will have a cylindrical
configuration when expanded), an oval configuration (in which case
deployable hoop expander 10 will have an ovoid shape when
expanded), or other shapes which may be determined by the organ or
cavity into which deployable hoop expander 10 is inserted, etc.
[0036] Furthermore, parallel rings 15 can have diameters which vary
along the length of deployable hoop expander 10, such that the
deployable hoop expander can form a particular non-cylindrical or
non-ovoid geometry when it is in its expanded cross-sectional
configuration. By way of example but not limitation, parallel rings
15 can have various diameters such that the deployable hoop
expander expands into a spherical configuration.
[0037] Additionally, deployable hoop expander 10 can be closed at
its distal end, and/or partially closed at its proximal end, and/or
partially closed at its proximal and distal ends, if desired.
[0038] Preferably, the proximal end of deployable hoop expander 10
comprises one or more guides 45 for receiving the distal end of
endoscopic instrument 35 relative to deployable hoop expander 10.
Among other things, guides 45 can be configured so as to allow
endoscopic instruments 35 to dock with deployable hoop expander 10,
so that guides 45 can act to steady or stabilize endoscopic
instruments 35 relative to deployable hoop expander 10 during an
endoscopic procedure. In this respect it will be appreciated that
providing a stable support platform for endoscopic instrument 35
can greatly facilitate stabilizing and aligning an instrument
relative to the anatomy when conducting tissue inspection, biopsy
and/or removal. This stable support platform can also enable and/or
facilitate more extensive surgical procedures such as full
thickness bowel resection (wall excision or segmental resection)
and/or repair during intestinal procedures, peritoneal exploration
(including natural orifice trans-endoscopic surgical procedures,
which are sometimes referred to as NOTES), treatment of
obstructions, and/or other complex endoscopic surgical
procedures.
[0039] The expansible nature of deployable hoop expander 10 is such
that it may be "sprung open" (i.e., transitioned from its reduced
cross-sectional configuration to its expanded cross-sectional
configuration) by a variety of means. Among other things, and as
will hereinafter be discussed in further detail, deployable hoop
expander 10 can be formed out of a spring material (e.g., a shape
memory alloy such as Nitinol, a hardened stainless steel wire, a
flexible plastic such as a self-expanding polymer, etc.) and
constrained by an outer net; or deployable hoop expander 10 can be
formed out of a spring material and constrained by an outer sheath;
or deployable hoop expander 10 can be manipulated between its
reduced cross-sectional configuration and its expanded
cross-sectional configuration by manipulating control wires
connected to struts 20; or by pinching one end of the device with a
specialized tool, thereby elongating and narrowing the device,
etc.
Deployable Hoop Expander Formed Out of Spring Material and
Constrained by an Outer Net
[0040] More particularly, and looking now at FIGS. 4 and 5, there
is shown a configuration in which parallel rings 15 of deployable
hoop expander 10 are formed out of a spring material (e.g., a shape
memory alloy such as Nitinol, a hardened stainless steel wire, a
flexible plastic such as a self-expanding polymer, etc.) and
constrained by an outer net 50. In one preferred form of the
invention, deployable hoop expander 10 is mounted over endoscopic
instrument 35, with deployable hoop expander 10 being maintained in
its reduced cross-sectional configuration using outer net 50.
Alternatively, deployable hoop expander 10 may be maintained in its
reduced cross-sectional configuration via outer net 50 and the
entire assembly delivered through a lumen of endoscopic instrument
35; or deployable hoop expander 10 may be inserted alongside of, or
entirely separately from, endoscopic instrument 35. In any case, in
use, after deployable hoop expander 10 has been delivered to the
therapeutic site, the net is withdrawn by pulling the net pull
wires 55 (FIGS. 6 and 7), thereby exposing and releasing parallel
rings 15. Upon net removal, parallel rings 15 automatically expand
(FIG. 8) so as to engage the side wall of the body lumen and
thereby expose, straighten and flatten the side wall tissue. At the
conclusion of the procedure, deployable hoop expander 10 may be
returned to its reduced cross-sectional configuration and removed
from the body lumen, or it may under certain circumstances remain
in place.
[0041] In another form of the present invention, and looking now at
FIGS. 9-11, net 50 may be loosened so as to release the restrained
deployable hoop expander 10, thereby allowing parallel rings 15 to
expand, but the net is still kept in place around the expanded
deployable hoop expander (FIG. 9). As a result, by forming net 50
with a closed distal end, the net can sit as a "trap" about the
therapeutic site so as to catch and retain anything which may be
removed or dislodged from the side wall of the body lumen during a
procedure. Thereafter, at the conclusion of the procedure,
deployable hoop expander 10 can be returned to its reduced
cross-sectional configuration and removed from the body lumen, and
then net 50 can be withdrawn from the body lumen (FIGS. 10 and 11),
carrying with it any tissue or debris removed from the side wall of
the body lumen and entrapped by the net. In this form of the
invention, it may be desirable to form net 50 with a distal end
reservoir 58 (FIG. 12) for storing excised tissue (e.g., biopsy
specimens) or dislodged debris.
Deployable Hoop Expander Formed Out of Spring Material and
Constrained by an Outer Sleeve
[0042] In another form of the invention, and looking now at FIGS.
13 and 14, there is provided a configuration in which deployable
hoop expander 10 is formed out of a spring material (e.g., a shape
memory alloy such as Nitinol, a hardened stainless steel wire, a
flexible plastic such as a self-expanding polymer, etc.) and
constrained by an outer sleeve 60. In one preferred form of the
invention, deployable hoop expander 10 is mounted over endoscopic
instrument 35, with deployable hoop expander 10 being maintained in
its reduced cross-sectional configuration using outer sleeve 60.
Alternatively, deployable hoop expander 10 may be maintained in its
reduced cross-sectional configuration via outer sleeve 60 and the
entire assembly delivered through a lumen of endoscopic instrument
35. Or deployable hoop expander 10 may be inserted alongside of, or
entirely separately from, endoscopic instrument 35. In any case, in
use, after deployable hoop expander 10 has been delivered to the
therapeutic site, the outer sleeve is removed, thereby releasing
parallel rings 15. With outer sleeve 60 removed, parallel rings 15
automatically expand so as to engage the side wall of the body
lumen and straighten and flatten the same.
Deployable Hoop Expander Erected with Control Wires
[0043] Looking next at FIGS. 15-17, there is shown a configuration
in which deployable hoop expander 10 can be manipulated by control
wires 65, 70 connected to struts 20 so as to expand parallel rings
15. In one preferred form of the invention, deployable hoop
expander 10 is mounted over an endoscopic instrument (not shown in
FIGS. 15-17), with the deployable hoop expander being maintained in
its reduced cross-sectional configuration. Alternatively,
deployable hoop expander 10 could be delivered through a lumen of
an endoscopic instrument, again with the deployable hoop expander
being maintained in its reduced cross-sectional configuration. Or
deployable hoop expander 10 may be inserted alongside of, or
entirely separately from, an endoscopic instrument. In any case, in
use, after deployable hoop expander 10 has been delivered to the
therapeutic site, the deployable hoop expander is erected by
pulling distally on control wire 65. This action erects the
deployable hoop expander so that it assumes its expanded
cross-sectional configuration (see FIGS. 15-17). Significantly, in
this form of the invention, deployable hoop expander 10 does not
need to be formed out of a resilient material, since the deployable
hoop expander is erected by pulling on control wire 65, and is not
erected by the resilient nature of the deployable hoop expander
itself.
[0044] Additionally, deployable hoop expander 10 can be collapsed
by releasing the previously-pulled control wire 65. Deployable hoop
expander 10 can then be moved by pulling on both control wires 65,
70. Once deployable hoop expander has been properly re-positioned,
it can be expanded again simply by pulling on control wire 65.
[0045] It should be appreciated that, in the configurations shown
in FIGS. 15-17, struts 20 are preferably connected to parallel
rings 15 with a hinge arrangement which allows the struts to pivot
relative to parallel rings 15. This hinge could be a pinned hinge,
a living hinge, etc.
Forming the Deployable Hoop Expander with a Helical
Construction
[0046] In another form of the invention, deployable hoop expander
10 may be formed with a helical construction. More particularly, in
this form of the invention, the plurality of parallel rings 15 may
be replaced by a helix, a double helix, another form of spiral, or
another collapsible/expandable polygonal structure defining a
volume. Where deployable hoop expander 10 is formed out of a helix,
double helix or another form of spiral, struts 20 may or may not be
provided.
[0047] Regardless of the particular construction chosen for the
deployable hoop expander, preferably at least a portion of the
deployable hoop expander has an open configuration (e.g., an open
lattice configuration) allowing access to the side wall of the body
lumen or body cavity.
Use of Grasping Tool for Re-Positioning or Removing the Deployable
Hoop Expander
[0048] Looking next at FIGS. 18-20, deployable hoop expander 10 may
also be retracted (e.g., for repositioning or complete removal)
with a specialized grasping tool 75. More particularly, specialized
grasping tool 75 comprises a hook 80 which can grasp the end-most
parallel ring 15 of the deployable hoop expander so as to cause the
entire device to elongate and narrow, thereby making it
re-positionable or removable.
Delivery of the Deployable Hoop Expander Vis-a-Vis an Endoscope or
Other Device
[0049] As noted above, deployable hoop expander 10 is designed such
that it can be delivered over an endoscope or other instrument, or
through the working channel of an endoscope or other instrument, or
it can be delivered alongside an endoscope or other instrument, or
entirely outside of or separate from an endoscope or other
instrument. See, for example, FIGS. 21 and 22, which show
deployable hoop expander 10 disposed in a channel 85 disposed
parallel to endoscopic instrument 35. Channel 85 may be affixed to
endoscopic instrument 35 in various ways, e.g., with an optional
snap-on ring 90.
Maintaining the Deployable Hoop Expander in the Body at the
Conclusion of an Endoscopic Procedure
[0050] It is anticipated that, in most cases, deployable hoop
expander 10 will be removed from the patient at the conclusion of
the endoscopic procedure. However, in some cases it may be
desirable to provide support to the vessel or organ for some period
of time after the conclusion of the endoscopic procedure. In this
case, deployable hoop expander 10 may be left in the body lumen at
the conclusion of the procedure and thereafter, when support is no
longer required, the deployable hoop expander can be removed from
the body. Optionally, deployable hoop expander 10 can be formed out
of a biodegradable/absorbable material. In this case, the device
can be left in the body at the conclusion of the endoscopic
procedure, whereupon it will thereafter biodegrade or be absorbed
by the body.
Applications
[0051] The novel endoscopic/surgical device of the present
invention can be used in substantially any endoscopic or surgical
procedure to facilitate the alignment and presentation of tissue
during an endoscopic procedure or to fix, dock, or stabilize the
working end of an endoscope or other instrument during such a
procedure.
[0052] The present invention is believed to have widest
applications with respect to the gastrointestinal (GI) tract, which
is generally characterized by frequent turns and which has a side
wall characterized by numerous folds. However, the methods and
apparatus of the present invention may also be used inside other
body cavities (e.g., the cranium, thorax, abdomen, pelvis, nasal
sinuses, chest, bladder, etc.) and other tubular viscera (e.g., the
esophagus, stomach, duodenum, vagina, ureter, fallopian tubes,
urethra, blood vessels, bronchi, etc.).
[0053] Thus, for example, the novel endoscopic device of the
present invention can be used in the performance of certain
specialized endoscopic procedures including Natural Orifice
Trans-Endoscopic Surgery (NOTES) procedures, as well as other
complex endoscopic procedures which could involve endoscopic
surgery.
Modifications
[0054] While the present invention has been described in terms of
certain exemplary preferred embodiments, it will be readily
understood and appreciated by one of ordinary skill in the art that
it is not so limited, and that many additions, deletions and
modifications may be made to the preferred embodiments discussed
above while remaining within the scope of the present
invention.
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